Job Title
Regulatory Affairs Associate
Experience
2-8 years of working experience in the regulatory affairs department.
Qualification
B Pharma / M Pharma
Job Role
Full‑time on‑site role for an Officer/Executive. The person will be responsible for pre‑ and post‑regulatory submissions in ROW, South Africa, MENA & WHO, ensuring compliance with company policies and procedures, collaborating with cross‑functional teams, and supporting new product development and post‑approval changes in manufacturing sites.
Responsibilities
* Management of product lifecycle for a particular market.
* Dossier preparation.
* Query response.
* Post‑approval changes.
* Variation filing.
* Co‑ordination with cross‑functional team.
* Module 1–5.
Skills Required
* Strong leadership, communication, and interpersonal skills.
* Excellent problem‑solving and analytical skills.
* Knowledge of pharmaceutical industry regulations and guidelines.
* Proficiency in Microsoft Office Suite and project‑management software.
* Bachelor’s or Master’s degree in Pharmacy.
Location
Mumbai [Andheri]
Contact
Please drop your updated CV on poojat@macleodspharma.com or gajendran@macleodspharma.com.
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